Puregon 50units0.5ml solution for injection vials

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Follitropin beta

Հասանելի է:

Merck Sharp & Dohme Ltd

ATC կոդը:

G03GA06

INN (Միջազգային անվանումը):

Follitropin beta

Դոզան:

100unit/1ml

Դեղագործական ձեւ:

Solution for injection

Կառավարման երթուղին:

Intramuscular; Subcutaneous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 06050100; GTIN: 5013257001473

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
PUREGON® 50 IU/0.5 ML_ _SOLUTION FOR INJECTION
PUREGON® 75 IU/0.5 ML_ _SOLUTION FOR INJECTION
PUREGON® 100 IU/0.5 ML SOLUTION FOR INJECTION
PUREGON® 150 IU/0.5 ML_ _SOLUTION FOR INJECTION
PUREGON® 200 IU/0.5 ML SOLUTION FOR INJECTION
PUREGON® 225 IU/0.5 ML SOLUTION FOR INJECTION
FOLLITROPIN BETA
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT PUREGON IS AND WHAT IT IS USED FOR
Puregon solution for injection contains follitropin beta, a hormone
known as follicle-stimulating
hormone (FSH).
FSH belongs to the group of gonadotrophins, which play an important
role in human fertility and
reproduction. In women, FSH is needed for the growth and development
of follicles in the ovaries.
Follicles are small round sacs that contain the egg cells. In men, FSH
is needed for the production of
sperm.
Puregon is used to treat infertility in any of the following
situations:
WOMEN
In women who do not ovulate and do not respond to treatment with
clomifene citrate, Puregon can be
used to cause ovulation.
In women undergoing assisted reproduction techniques, including
_in vitro_
fertilisation (IVF) and other
methods, Puregon can bring about the development of multiple
follicles.
MEN
In men who are infertile due to lowered hormone levels, Puregon can be
used for the production of
sperm.
1.
WHAT PUREGON IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PUREGON
3.
HOW TO USE PUREGON
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PUREGON
6.
CONTENTS OF TH

Ապրանքի հատկությունները

OBJECT 1
PUREGON 50 IU/0.5 ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 08-Jun-2016 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Puregon® 50 IU/0.5 mL solution for injection
Puregon® 75 IU/0.5 mL solution for injection
Puregon® 100 IU/0.5 mL solution for injection
Puregon® 150 IU/0.5 mL solution for injection
Puregon® 200 IU/0.5 mL solution for injection
Puregon® 225 IU/0.5 mL solution for injection
2. Qualitative and quantitative composition
Puregon 50 IU/0.5 mL solution for injection
One vial contains 50 IU recombinant follicle-stimulating hormone (FSH)
in 0.5 mL aqueous solution.
This corresponds to a strength of 100 IU/mL. One vial contains 5
microgram of protein (specific _in vivo_
bioactivity equal to approximately 10,000 IU FSH / mg protein). The
solution for injection contains the
active substance follitropin beta, produced by genetic engineering of
a Chinese hamster ovary (CHO) cell
line.
Puregon 75 IU/0.5 mL solution for injection
One vial contains 75 IU recombinant follicle-stimulating hormone (FSH)
in 0.5 mL aqueous solution.
This corresponds to a strength of 150 IU/mL. One vial contains 7.5
microgram of protein (specific _in vivo_
bioactivity equal to approximately 10,000 IU FSH / mg protein). The
solution for injection contains the
active substance follitropin beta, produced by genetic engineering of
a Chinese hamster ovary (CHO) cell
line.
Puregon 100 IU/0.5 mL solution for injection
One vial contains 100 IU recombinant follicle-stimulating hormone
(FSH) in 0.5 mL aqueous solution.
This corresponds to a strength of 200 IU/mL. One vial contains 10
microgram of protein (specific _in vivo_
bioactivity equal to approximately 10,000 IU FSH / mg protein). The
solution for injection contains the
active substance follitropin beta, produced by genetic engineering of
a Chinese hamster ovary (CHO) cell
line.
Puregon 150 IU/0.5 mL solution for injection
One vial contains 150 IU recombinant follicle-stimulating hormone
(FSH) in 0.5 mL aqueous solution.
This corres